Boston Scientific Corporation – Galway · Boston Scientific Corporation Galway (BSC Galway) is a...

Boston Scientific Corporation, Galway

of 32

Boston Scientific Corporation – Galway

IPPC Licence Number P0725-01

Annual Environmental Report 2010 &

Environmental Management Programme 2011

Ballybrit Business Park, Galway, Co. Galway


of 32

Opening Comments This is Boston Scientific’s fifth Annual Environmental Report (AER), and the story of

continuous Environmental improvement continues.

During 2010 we achieved a 5% reduction in our greenhouse gas emissions (carbon dioxide).

This was achieved through several energy initiatives, most notable among these being the

reduction in Cleanroom Air changes during un-occupied times. We also continue to take

advantage of the Combined Heat and Power (CHP) plant which has allowed us to replace

the fuel oil in our boilers with natural gas as well as gaining increased efficiency in power

generation.

The recycling initiatives introduced towards the end of 2009 helped us to recycle 75% of our

non-hazardous waste in 2010.

All of the above environmental benefits have been gained through careful management of

our environmental programme as an integral part of our business and we will continue this

journey of improvement in cooperation with the EPA and other key stakeholders in

environmental protection.


of 32

CONTENTS

1. INTRODUCTION 4 1.1 Company Information 4 1.2 Environment Health and Safety (EHS) Policy 6 1.3 Organisation Chart for Environment, Health & Safety Management 7

2. SUMMARY INFORMATION 8 2.1 Monitoring Data 8 2.2 Waste Management 16 2.3 Agency Monitoring & Enforcement 19 2.4 Energy & Resource Consumption Summary 20 2.5 Environmental Incidents and Complaints 23

3. MANAGEMENT OF THE ACTIVITY 24 3.1 Introduction 24 3.2 BSC Galway Register of Aspects/Impacts for 2010 25 3.3 Status Report on 2009 Schedule of Objectives and Targets 26 3.4 Proposed Schedule of Objectives and Targets 28 3.5 Solvent Management 30

4. RESIDUALS MANAGEMENT PLAN AND ENVIRONMENTAL LIABILITIES RISK ASSESSMENT 31 4.1 Residuals Management Plan (RMP) 31 4.2 Environmental Liabilities Risk Assessment (ELRA) 31 4.3 Financial Provision for RMP & ELRA 31

5. LICENCE SPECIFIC REPORTS 32


of 32

1. INTRODUCTION

1.1 Company Information

Boston Scientific Corporation (BSC) was founded in 1979. It is one of the

world’s largest medical device company dedicated to the development of less

invasive therapies. These therapies provide effective alternatives to traditional

surgery by reducing procedural trauma, complexity, and risk to the patient, cost

and recovery time. The devices are generally inserted into the human body

through natural openings or small incisions in the skin and can be guided to most

areas of the body to diagnose and treat a wide range of medical problems.

BSC’s products are mainly used in the areas of cardiology, neuroradiology,

neuromodulation, gastroenterology, pulmonary medicine, radiology, urology and

vascular surgery.

The corporate headquarters is located in Natick Massachusetts and the

company employs 25,000 people with operations in 26 manufacturing,

distribution and technology centres worldwide.

Galway Information

Boston Scientific Corporation Galway (BSC Galway) is a medical devices facility,

located on a 23-acre site within the Ballybrit Upper Business Park, in Galway.

The Galway manufacturing and research and development facility was

established in 1994. Currently, BSC Galway has approximately 2,800

employees, making it the largest multinational company in the West of Ireland.

Galway manufactures products for the organisation’s main product ranges using

a full array of on-site technologies, rendering it virtually self-sufficient in the

supply of its own sub assemblies. BSC Galway’s products span 60 categories

and include more than 14,500 product variants.

The main three product areas are:

Interventional Cardiology - Cardiovascular disease is caused by narrowed or

blocked blood vessels in the heart. This disease can be treated through the use

of balloon catheter, stent and drug-eluting stents products.


of 32

Peripheral Interventions – Peripheral vascular disease occurs when the

arteries that carry blood to vessels outside of the heart and brain become

narrowed or blocked by plaque, slowing or stopping the flow of blood. This

disease is treated less invasively using angioplasty and stenting therapies

Endosurgery – A variety of self-expanding metal stents to provide patients with

palliative relief for malignant strictures in the colon, duodenum, common bile duct

and oesophagus. In addition, silicone-coated stents provide treatment options for

managing some recurrent or inoperable benign strictures of the oesophagus and

central airway.

The Annual Environmental Report (AER) has been prepared for the calendar

year of 2010. Reference has been made to the EPA Guidance Note for: “Annual

Environmental Report” in preparing this report.


of 32

1.2 Environment Health and Safety (EHS) Policy

Environment, Health & Safety Policy

Protecting our Planet, our People and our Property

Boston Scientific believes that leading environmental, health and safety performance contributes to our competitive strength and benefits our customers, shareholders and employees. The safety of our workforce and the protection of our environment are of primary importance to Boston Scientific. To protect our employees, the environment and our property, we are committed to: providing a safe and healthy working environment as a prerequisite to our operations; continuous improvement in minimizing our environmental impacts and the depletion of natural resources; and preventing pollution.

Boston Scientific will comply with applicable environmental, health and safety laws, directives, regulations and other requirements as a baseline for doing business, not as a goal. We believe compliance is owned by all employees, and will monitor such compliance through regular self-assessments and audits of our operations, take corrective actions as warranted, and include compliance sustainability as a routine part of operations.

We will periodically identify those aspects of our operations on a local level which have the most significant environmental, health and safety impact, and establish objectives and targets for continuous improvement in these areas. In particular, we will work to advance the following aspects within our operations:

• Minimizing the generation of solid and hazardous waste, and recycling wastes where feasible

• Optimizing energy and resource use and efficiency with a goal of reducing green house gas emissions

• Controlling and limiting emissions to the atmosphere • Reducing workplace injuries and incidents • Reducing ergonomic and manual handling risks in the workplace

Environmental, health and safety targets and objectives will be set by senior management, communicated to employees, measured and tracked on a regular basis, and revised as needed to reflect current conditions. In order to facilitate this, Boston Scientific will provide appropriate training and resources for employees to use responsible environmental, health and safety practices.

We require our employees to make sound environmental, health and safety management an integral part of their job. Management will demonstrate environmental, health and safety leadership and help build a culture across the company where all employees embrace this policy and these guiding principles as their responsibility.

Ray Elliott Leonard Sarapas

President and CEO Corporate Director, EH&S

S842730-00 Revision AG


of 32

1.3 Organisation Chart for Environment, Health & Safety Management

DirectorSite Services

EHS/ProgramsManager

Vice PresidentOperations

CorporateEHS

Function

FacilitiesEngineering

FacilitiesManager

FacilitiesCo-ordinator

EHS Specialists

OccupationalHealth Advisors


of 32

2. SUMMARY INFORMATION

2.1 Monitoring Data

2.1.1 Emissions to sewer

There are two emission points for process effluent for the site. These emissions

points, SE1 and SE2, are monitored via monitoring chambers prior to combining

with the foul sewer which joins the Galway City Council Municipal sewer, which

in turn feeds on to the Mutton Island Waste Water Treatment Plant.

SE1 services the phase 1 production area, and SE2 services the phase 2 and 3

production areas. The emissions from both points consist of the combined flow

associated with employee hand washing, cooling of extruded plastic, leak testing

of products, water “drag-out” tanks from the balloons and metals finishing

processes. See Tables 2.1 to 2.2 for monitoring results for SW1 and SW2.

Table 2.1 Trade Effluent Emissions to Sewer SE1

Parameter Emissions 2009 MEV

Emissions 2010 MEV

Licensed MEV

Volume (m3) 7,182 7,634 27,375 Temperature Range (°C) 13 – 22 11 – 22 35 (max)

pH Range (Daily Average) 7.6 – 8.2 7.6 – 8.1 5 – 10 Other Parameters MEV kg MEV kg MEV kg

BOD* 14,187* 11,396* 53,655*

COD 25,077 17,131 139,795

Suspended Solids 116 23 6,935

Sulphates 456 431 10,950

Detergents 7 8 2,738

Oils, Fats and Greases 7 23 2,738

Total Phosphorus (as P) 0.5 0.3 274

Cadmium (as Cd) 0.0004 0.0001 2.7

Copper (as Cu) 2 0.3 55

Lead (as Pb) 0.01 0.002 13.7

Zinc (as Zn) 0.7 0.2 13.7

Chromium (as Cr) 0.01 0.005 8.2

Nickel (as Ni) 0.02 0.001 8.2

Tin (as Sn) BDL 0.003 27.4 MEV = Mass Emission Value BDL = Below detectable limits * See text note below Table 2.2


of 32

Table 2.2 Trade Effluent Emissions to Sewer SE2

Parameter Emissions 2009 MEV

Emissions 2010 MEV

Licensed MEV

Volume (m3) 9,581 19,687 54,750 Temperature Range (°C) 12 - 21 9 – 20 35

pH Range (Daily Average) 7.9 – 8.5 7.7 – 8.3 5 – 10 Other Parameters MEV kg MEV kg MEV kg

BOD* 14,187* 11,396* 53,655* COD 2,617 2,397 279,225

Suspended Solids 91 108 13,870

Sulphates 596 1,013 21,900

Detergents 6 36 5,475

Oils, Fats and Greases 112 531 5,475

Total Phosphorus (as P) 9 226 548 Cadmium (as Cd) 0.002 0.001 5.48

Copper (as Cu) 2 2 110

Lead (as Pb) 0.01 0.01 27

Zinc (as Zn) 0.3 0.5 27

Chromium (as Cr) 0.02 0.2 16

Nickel (as Ni) 0.02 0.1 16

Tin (as Sn) BDL BDL 55 MEV = Mass Emission Value BDL = Below detectable limits * See text note below Table 2.2

* With the agreement of Galway City Council, a Technical Amendment to BSC

Galway’s IPPC licence was issued by the Environmental Protection Agency on

the 15th December 2008 whereby a consolidated SE1 and SE2 BOD mass ELV

of 147 kg per day was implemented, giving a combined annual mass ELV of

53,655 kg.

As can be seen from Tables 2.1 and 2.2 the annual mass emissions for all

process effluent parameters for 2010 are all well below the emission limit values.

Table 2.3 outlines the individual IPPC Licence non-compliances that occurred

during 2010 for process/trade effluent parameters.


of 32

Table 2.3 Trade Effluent Sewer Emissions – Non-compliance Summary

Date Non-compliance Cause Corrective Action

27/01/2010 Intermittent failure of

continuous monitoring of

pH/Temp/Flow data for

SE2

Review of

monitoring

equipment did not

identify any issues,

equipment failure

attributed to

extreme weather

conditions

Operation of

monitoring

equipment

reviewed

29/01/2010 Exceedance of hourly

SE1 pH ELV. pH value

of 4.9 recorded – limit 5

Cleaning of site

purified water

system RO

membranes

Implemented

procedure to notify

EHS when cleaning

RO membranes

12/07/2010 Failure of continuous

monitoring SE1 pH

probe

Probe failure Probe replaced

11/02/2010

03/03/2010

14/04/2010

30/04/2010

03/06/2010

01/07/2010

12/08/2010

01/09/2010

Exceedance of the

monthly SE2 ELV for

Phosphorous for the

months of January

through August. Values

(mg/l) of 17.2, 15.4,

14.0, 13.9, 18.8, 16.2,

12.1 & 10.7 were

recorded – limit 10 mg/l

Carry over of

phosphoric acid

into rinse water

released to drain

Diverted rinse

water for collection

and disposal as

hazardous waste.

29/07/2010 Exceedance of the pH

ELV for SE1 for a period

of 5 hours, pH’s values

of 10.02, 10.12, 10.11,

10.07 & 10.01 recorded

– limit 10

Rinsing of new

carbon filtering

media for the

purified water

treatment process.

Carbon is replaced

annually.

No corrective action

implemented as pH

was only marginally

over limit and

environmental

impact was minimal

ELV = Emission Limit Value

All non-compliances were reported to the Agency in a timely manner.


of 32

2.1.2 Emissions to surface water

There are no emissions to surface waters from the facility. Rainwater falling on

roofs and hardstand areas of the site drains via the surface water emission point

(SW-1) to the Galway City Council storm water sewer system and eventually on

to Galway Bay. Table 2.4 lists the monitoring data for SW1.

Table 2.4 Surface Water Runoff Emissions (SW1)

Parameter 2009 Average Value

2010 Average Value

pH 7.2 7.0

Chemical Oxygen Demand (COD mg/l) 35 84

Total Organic Carbon (TOC mg/l) <0.01 <0.01


of 32

2.1.3 Emissions to Air

The main emissions to air from the BSC Galway site are as a result of

combustion to provide electricity, heat and hot water for the site and to control

temperature and humidity in the cleanrooms.

There are 8 (no.) boilers and 1 (no.) CHP unit available to operating on the site

as detailed in Table 2.5.

Table 2.5 Boiler and CHP Information

No. Usage Plan Fuel Capacity Operation Scenario

A1-1 Wilson Boiler Diesel 700 kW Demand driven

A1-2 Phase 1-2 Area Support Boiler

Natural Gas 1,450 kW Support to CHP – demand driven

A1-3 Support Boiler Dual Fuel Natural Gas/ Diesel

1,450 kW Support to CHP – demand driven. Diesel use only in the event of interruption of NG supply

A1-4 Support Boiler Dual Fuel Natural Gas/ Diesel

1,450 kW Support to CHP – demand driven. Diesel use only in the event of interruption of NG supply

A1-5 Phase 3 Area Support Boiler

Natural Gas 1,450 kW Demand driven if NG boilers cannot meet demand

A1-6 Back-up Boiler Diesel 1,450 kW Back-up in the event of interruption of NG supply

A1-7 Back-up Boiler Diesel 640 kW Back-up in the event of interruption of NG supply

A1-8 Back-up Boiler Diesel 1,450 kW Back-up in the event of interruption of NG supply

A1-9 CHP Plant Natural Gas 1,088 kW Full time

The CHP plant reduces the import of electricity by 999kWe and replaces

1088kWt of heat generated by our conventional boilers. The eight boilers and

CHP plant provide a potential total of 11,129 kW (11MW) capacity for the site.

The CHP plant A1-9 is the primary thermal source, with boilers A1-2 and A1-5

acting as support boilers if demand requires. Boiler A1-1 is not tied into the

natural gas pipeline on site and operates as a diesel fired boiler. The natural

gas boilers A1-3 and A1-4 act as back-up boilers. The remaining diesel boilers

A1-6, A1-7 and A1-8 are not operational under normal conditions.


of 32

The monitoring results for the boilers and CHP Plant are summarised in Table

2.6 and 2.7.

Table 2.6 Boiler Emissions

Emission Point

Combustion Efficiency (%)

Mass Emissions Tonnes

NOx

Mass Emissions Tonnes

SO2 A1-1 79% 0.67 0.32

A1-2 93% 0.23 0.16

A1-3 93% 0.48 0.10

A1-4 94% 0.31 0.09

A1-5 95% 0.30 0.13

A1-6 92% 0.08 0.08

A1-7 87% 0.00 0.00

A1-8 87% 0.00 0.00

A1-9 63% 23.94 0.00

* Note: The 63.4% efficiency only represents the CHP electrical efficiency and does not include thermal 0.00

Generator emissions

There are 4 (no.) generators available to operate on site as follows:

A1-57 704kW diesel-fired generator




The emergency generators, A1-57 through A1-60 only provide a back-up power

supply to the plant in the event of loss of normal power supply or loss of the CHP

capacity. The emergency generators did not run in 2010 except for

maintenance.

The monitoring results for the generators are summarised in Table 2.8.


of 32

Table 2.8 Generator Emissions

Emission Point Combustion Efficiency (%)

A1-57 92.90

A1-58 92.92

A1-59 92.93

A1-60 92.98

The greenhouse gas emissions from the CHP, boilers and generators are

summarised below in Table 2.9.

Table 2.9 Green House Gas Emissions Direct

Emission Points 2010 CO2 Mass Emissions (Tonnes)

2009 CO2 Mass Emissions (Tonnes)

Diesel Boilers/Generators A1-1, A1-6, A1-7, A1-8, A1-57, A1-58, A1-59 and A1-60

541

CHP A1-9 4,045

NG Boilers A1-02, A1-03, A1-04, A1-05

1,730

5,238


of 32

2.1.4 Noise Survey

A Noise Survey was carried out by AWN Consulting for BSC Galway, to

demonstrate that the noise climate at noise-sensitive locations in the vicinity of

BSC Galway is in accordance with Condition 6.13 of the facility’s IPPC licence.

Schedule B.4. of the Licence stipulates the following Noise Limits for emissions

from the facility at the nearest noise-sensitive receptors.

Daytime (08:00hrs to 22:00hrs): 55dB(A) LAeq (30 Minutes)

Night-time (22:00hrs to 08:00hrs): 45dB(A) LAeq (30 Minutes)

Two environmental noise surveys, one daytime and one night-time, have been

carried out at the two designated noise-sensitive locations (NSL) in the vicinity of

the site and also at selected boundary locations.

It is evident from the 2010 environmental noise survey that the Boston Scientific

Corporation Galway facility is in compliance with the relevant noise conditions

specified in Schedule B of its IPPC Licence. There were no tonal components or

impulsive properties during the day-time or night-time periods at any of the

monitoring locations. Noise emissions associated with the facility were not

audible at either of the noise-sensitive locations.

A copy of the Noise Monitoring Report is provided in Attachment 1.


of 32

2.2 Waste Management

In order to minimise the impact of the waste generated on site, the site has

focused on the segregation of different waste types to ensure that waste material

can be re-used where possible, and otherwise recycled or disposed of in a safe

and appropriate manner.

BSC Galway has an ongoing waste reduction and recycling programme as part

of the Environmental Management System (ISO 14001) and recycling goals and

objectives are an essential part of the site environmental programme. For 2011,

BSC Galway has set a goal to increase the percentage of non-hazardous waste

diverted from landfill to 77% from the 2010 target of 75%

Table 2.10 quantifies the volume of non-hazardous waste that is recycled and

the volume of all waste types arising on site.

Table 2.10 Waste Arising on Site

Waste Type 2009 Tonnes

2010 Tonnes

Non-hazardous Waste for Recycling 570 649

Hazardous Waste 468 469

Non-hazardous Waste to Landfill 242 210

Total Waste Arising on Site 1,280 1,328

Records for all waste shipments sent off-site, including waste contractor

documentation, TFS (Transfrontier Shipment) forms and C1 Consignment forms,

are held on site and are available for review.

Annual waste arising is summarised in Table 2.11 and Table 2.12 below.

.


of 32

Table 2.11 Annual Non-hazardous Waste Arising

EWC Code

Waste Description Main Source Tonnes

2009

Further Treatment (Method, Location

& Undertaker)

Recovery, Reuse or Recycling

Final Disposal (Method,

Location & Undertaker)

15 01 06 General Waste Non-recyclable waste 209.98 None None Landfill, Greenstar

15 01 01 Cardboard Warehouse 138.30 Segregated on site Recycled via Barna Waste N/A

20 01 08 Compostable Waste Canteen 131.11 Segregated on site Composted via Barna Waste N/A

15 01 03 Timber Warehouse 104.21 Segregated on site Recycled via Barna Waste N/A

15 01 06 Mixed Recyclables Site Wide 82.05 Segregated off site Recycled via Barna Waste N/A

20 01 01 Paper Office Areas 55.25 Segregated on site Recycled via Barna Waste N/A

15 01 02 Plastic Production 37.46 Segregated on site Recycled via Barna Waste N/A

20 01 40 Metal Scrap Facilities / Canteen 57.42 Segregated on site Recycled via Barna Waste N/A

20 01 36 WEEE Production 17.76 Segregated on site Recycled via Barna Waste N/A

20 01 02 Glass Production/ Canteen 17.20 Segregated on site Recycled via Barna Waste N/A

20 01 25 Cooking Oil Canteen 7.07 Segregated on site Recycled via Frylite N/A

08 03 18 Toners Site Wide 0.98 Segregated on site Recycled via HP N/A

Totals 859


of 32

Table 2.12 Annual Hazardous Waste Arising

EWC Code Waste Description Quantity Tonnes

Method of Disposal/ Recovery Location of Disposal/ Recovery

Name of Waste Disposal/Recovery Contractor

06 01 06* Aqueous Acids 292.20 Physico-Chemical Treatment Ireland Enva (Shannon)

07 01 04* Organic Solvents 79.25 Recovery England SRM Ltd (Mor)

07 05 13* Solid Wastes 65.48 Incineration Netherlands ATM

15 02 02* Absorbents & Filters 7.30 Incineration Netherlands ATM

13 08 99* Oils 5.24 Incineration Netherlands ATM

15 01 10* Empty Packaging 4.73 Incineration Netherlands ATM

07 01 99 Hydropass 3.59 Incineration Netherlands ATM

08 01 11* Waste Paint 2.47 Incineration Netherlands ATM

16 06 01* Batteries 1.80 Recovery Ireland Electrical Waste Management

16 05 08* Glycerine 1.54 Incineration Netherlands ATM

20 01 35* WEEE 1.50 Recovery Ireland KMK

13 03 10* Ethylene Glycol 1.09 Incineration Netherlands ATM

18 01 03* Bio-hazardous Waste 0.99 Autoclave Ireland Eco-Safe Systems Ltd

13 01 13* Hydraulic Oil 0.66 Incineration Netherlands ATM

20 01 21* Fluorescent Tubes 0.37 Recovery Ireland Irish Lamp Recycling Ltd

20 01 33* Batteries 0.33 Recovery Ireland KMK

Totals 469


of 32

2.3 Agency Monitoring & Enforcement

Agency Personnel visited the site four times during 2010

1. June 29th 2010 – The Agency attended the site to take process effluent and

surface water samples at locations SE1, SE2 and SW1. All results complied

with the emission limit values (ELV's) set out in the IPPC licence.

2. September 2nd 2010 - The Agency carried out an un-announced audit of the

facility. The Agency found the site to be compliant to its IPPC Licence

requirements and commended the facility on its environmental management.

3. September 14th 2010 – The Agency attended the site to take process effluent

and surface water samples at locations SE1, SE2 and SW1. All results

complied with the ELV's set out in the IPPC licence.

4. November 10th 2010 – The Agency attended the site to take process effluent

and surface water samples at locations SE1, SE2 and SW1. All results

complied with the ELV's set out in the IPPC licence.


of 32

2.4 Energy & Resource Consumption Summary

2.4.1 Electricity, Fuel & Gas Consumption

Table 2.13 below provides a summary of the annual energy, fuel and natural gas

consumption and Table 2.14 provides the quantification of greenhouse gases

associated with electricity generation and use.

Table 2.13 Electricity, Fuel & Gas Consumption

Item 2009 Quantity 2010 Quantity

Electricity (MWh) Imported 28,114 22,526

Electricity (MWh) CHP Generated 2,934 8,413

Fuel Oil (m3) 1,105 0

Diesel (m3) 198 202

Natural Gas (m3) 869,944 2,864,085

Table 2.14 Electricity Greenhouse Gas Indirect Emissions

Item 2009 CO2 Mass Emissions Tonnes

2010 CO2 Mass Emissions Tonnes

Imported Electricity 11,527 9,235

Energy management forms a significant part of BSC Galway’s environmental

programme and the site has installed a natural gas fired, combined heat and

power (CHP) plant which has resulted in the removal of fuel oil from the site and

a reduction in greenhouse gas emissions.

2.4.2 Water Consumption

There are five grades of water used at BSC, Galway:

(1) Non-potable Water: Used to feed the humidifiers at the air handling units.

(2) Softened Water: Used for dish-washing facilities within the canteen area.

(3) Purified Water: Used in the manufacture of implantable medical devices.

(4) Reverse Osmosis Water: (similar to purified water): Used in the manufacture

of implantable medical devices.


of 32

(5) Potable Water: Used for the canteen area, drinking water and make-up water

for the chiller water losses.

Very little trade effluent is generated by BSC Galway’s production activities. The

trade effluent is associated in the main with employee hand washing which is

requirement for all personnel entering a controlled environment area, cooling of

extruded plastic, leak testing of products and water drag-outs tanks from the

metals finishing process.

Table 2.15 contains details on overall site water consumption and the volumes of

trade effluent released to sewer.

Table 2.15 Water & Trade Effluent Emissions to Sewer

2009 Volume (m3)

2010 Volume (m3)

Licensed Volume (m3)

Total Site Water Use 103,183 101,407 N/A

Trade Effluent SE1 7,182 7,634 27,375

Trade Effluent SE2 9,581 19,687 54,750

2.4.3 Raw Material Consumption

There are four main raw materials used in the manufacturing processes:

1. Chemicals - Include adhesives and solvents required for the process.

Received in small plastic/metal/glass containers (20 ml to 200 litres) into the

chemical store area of the warehouse. Acid and alkaline chemical solutions

are received into an external chemical handling room in 1m3 intermediate

bulk containers (IBC).

2. Metals - Stainless steel/platinum chromium alloy are received in tubes

weighing 10g - 500g. Wire is received in spools (approx. 200-300 g per

spool). The stainless steel, platinum chromium alloy and wire are used to

form stents. Metal product sub-assemblies i.e. guidewires, markerbands and

hypotubes along with metal production aids like mandrels, needles and

fixtures are also received.


of 32

3. Plastics - Plastic resins are received into the warehouse in bags or

containers of resin 5kg - 40kg. Plastic product sub-assemblies i.e. valves,

hubs and tubing are also received.

4. Packaging - Product is packaged by placing or clipping the product into

preformed trays and/or sealed in pouches. The sealed product is placed

along with directions for use in a paperboard box. The boxed product is then

placed in larger corrugated cardboard boxes for shipping.

BSC Galway uses Lean Manufacturing as its production operating system, which

relentlessly pursues, through continuous improvement, the elimination of

activities (waste) that do not add value for the customer. All lean activities take a

designed approach to continuous improvement. Adherence to the Lean

philosophy is pursued through the implementation of Core Metrics for each

production area to include a Lean Metric. Raw material usage and waste are

controlled via a scrap improvement metric.


of 32

2.5 Environmental Incidents and Complaints

2.5.1 Environmental Incidents

There was no environmental incident in 2010. Incidents relating to licensed

emission to sewer limit values have been recorded earlier in Table 2.3.

2.5.2 Environmental Complaints

No environmental complaints were received in 2010 from employees, the local

community or businesses.


of 32

3. MANAGEMENT OF THE ACTIVITY

3.1 Introduction

BSC Galway considers environmental protection an essential requirement of its

operations and undertakes to conduct its business in a manner which protects

the environment of the customers, employees and communities in which it

operates.

BSC Galway, in accordance with the Corporate EHS Policy strives to:

Minimise pollution from all its activities

Reduce the impact of its environmental aspects, having particular regard to:

- Aqueous Discharges

- Air Emissions

- Waste Management

- Use of Natural Resources (water, gas etc)

- Use of Energy

- Use of Raw Materials

- Potential Accidents and Emergencies

- Suppliers and Contractors

Implement continual improvement and prevention of pollution in all its

operations by regularly setting and reviewing environmental objectives and

targets

Conduct all its activities in compliance with EU and national legislation

Make the environmental policy and objectives and targets available to

employees, other interested parties, and the public on request.

BSC Galway implemented an Environmental Management System in June 2000

and this provides a formal and internationally-recognised system for

environmental management, ongoing assessment of environmental

performance, and continual improvement at the facility. Every year the facility

reviews the environmental impacts resulting from its operation and develops a

programme of objectives and targets to address the significant aspects

associated with its activities. The Register of Aspects/Impacts for 2011, the

status of the objectives and targets for 2010, and the proposed objectives and

targets for 2011 are outlined in sections 3.2, 3.3, and 3.4 respectively.


of 32

3.2 BSC Galway Register of Aspects/Impacts for 2011

Impact

Seve

rity

Freq

uenc

y

Con

trol

Sub

Tota

l (EC

)

Lega

l

Publ

ic Im

age

Cha

nge

Diff

icul

ty

Sub

Tota

l (B

C)

Max scores>>>>>>>>>>>>>>>>>>>>>> 5 5 5 15 3 3 3 9 135A1 Energy & Resource Usage Depletion of natural resources & creation

of greenhouse gases 2 5 3 10 2 2 2 6 60

A2 Hazardous Waste Natural resource depletion, contamination of land, sea, air & water 4 4 2 10 1 3 1 5 50

A3 Aqueous Discharges Contamination of Galway Bay1 4 3 8 2 2 2 6 48

A4 Major Emergency Contamination of air, water and/or groundwater 2 1 3 6 2 3 2 7 42

A5 Emissions to Atmosphere Air contamination & greenhouse gas creation 1 5 3 9 2 1 1 4 36

A6 Contaminated Land / Groundwater

Contamination of land or groundwater1 4 3 8 2 1 1 4 32

A7 Non-hazardous Waste Natural resource depletion, air, soil & groundwater contamination from landfill leachate & gas emissions

1 4 2 7 1 1 2 4 28

A8 Hazardous Materials Contamination of air, land, soil or water & depletion of natural resources 2 4 1 7 1 2 1 4 28

A9 Contract Services Air, noise, surface water, groundwater or soil contamination 2 4 1 7 1 1 2 4 28

A10 Environmental Noise Noise pollution1 5 1 7 1 1 1 3 21

A11 Visual Impact Visual appearance1 5 1 7 1 1 1 3 21

A12 Ecosystems Damage to flora, fauna1 4 1 6 1 1 1 3 18

A13 Transport Air quality degradation, resource depletion and hazardous waste generation.

1 4 1 6 1 1 1 3 18

A14 Supply Side Activities Contamination of air, land, soil or water & depletion of natural resources 1 4 1 6 1 1 1 3 18

A15 Product Stewardship Contamination of air, land and depletion of natural resources 1 4 1 6 1 1 1 3 18

A16 Process, Equipment & Material Introduction

Depletion of natural resources, contamination of land, sea, air & water 2 1 2 5 1 1 1 3 15

A17 Decommissioned Plant or Equipment

Air, land or water contamination1 3 1 5 1 1 1 3 15

Aspect/Activity No. & Description Environmental Concerns (EC)

Business Concerns (BC)

At a minimum yellow shaded aspects are included in the current Environmental Management Programme

Tota

l Rat

ing

(EC

x B

C)


of 32

3.3 Status Report on 2010 Schedule of Objectives and Targets

3.3.1 Objective 1 – Optimise Energy & Resource Usage and Reduce Emissions to Atmosphere Impact/Target Objective Action Due Date Status

Management of Energy &

Resource Use

Reduce the generation of

greenhouse gas emissions by 3%

from the 2009 baseline.

Identify and implement feasible energy saving

projects derived from the site Energy

Management LBP for example:

• Reduction in clean-room air changes.

Q4, 2010

Complete

Management of

Atmospheric Emissions

Eliminate use of ozone-depleting

hydro chlorofluorocarbons

(HCFC’s) on site.

Replace existing chillers with equipment that is

compliant to the latest legislative requirements.

Q4, 2014

Complete

Achievement: The site reduced greenhouse gas generation by 7% from the 2009 baseline. One chiller using the HCFC R22 was replaced in 2010 and the site is on track to meet HCFC requirements by 2014.

3.3.2 Objective 2 – Improve Control & Management of Hazardous Waste Impact/Target Objective Action Due Date Status

Hazardous Waste

Management

Reduce the volume of hazardous

waste sent for incineration by 2%

from 2009 baseline.

Investigate options to segregate drug eluting

stent sharp waste into reusable containers to

reduce packaging volume being disposed as

hazardous waste.

Complete all bund repairs as identified in the

December 2009 Bund Integrity report.

Q3, 2010

Q4, 2010

Complete

On track

Achievement: The site reduced volume of hazardous waste sent for incineration by 29% from the 2009 baseline. 75% of bund repairs completed, remaining minor non-structural repairs on external bunds are weather dependant and will be completed early in Q2.


of 32

3.3.3 Objective 3 - Minimise the Environmental Impact of Aqueous Discharge and Contaminated Land/Groundwater Impact/Target Objective Action Due Date Status

Minimise impact of

Aqueous Discharges &

Contaminated Land /

Groundwater

Implement recommendations of

2010 CC TV Pipeline Survey.

• Repair all Grade Four observations identified

in the Survey.

• Repair all Grade Three observations

identified in the Survey.

Q4, 2010

Q4, 2011

Complete

On track

Achievement: All grade four observations repaired.

3.3.4 Objective 4 – Minimise the Environmental Impact of Non-Hazardous Waste Impact/Target Objective Action Due Date Status

Non-hazardous Waste

Management

Divert 75% of non-hazardous

waste generated on site from

Landfill.

• Identify infrastructure requirements needed to

expand the diversion of canteen waste from

landfill to recycling.

• Identify additional potential waste streams to

divert from landfill.

Q2, 2010

Q4, 2010

EHS

EHS

Achievement: The site recycled 75% of non-hazardous waste created on site.


of 32

3.4 Proposed Schedule of Objectives and Targets

3.4.1 Objective 1 – Optimise Energy & Resource Usage and Emissions to Atmosphere Impact/Target Objective Action Due Date Responsibility

Management of Energy &

Resource Use

Reduce the volume of electricity

required per DES product

manufactured by 5% from the

2010 baseline.

Using the energy LBP, install individual meters in

the DES area’s to record the electricity required

to manufacture DES products.

Q4, 2011

LBP Team/FET

Develop systems to carbon

footprint DES products.

Using the energy LBP metering to record the

volume of electricity required in DES areas.

Q2, 2011

EHS/FET

Management of

Atmospheric Emissions

Eliminate use of ozone-depleting

hydrochlorofluorocarbons

(HCFC’s) on site.

Replace existing chillers with equipment that is

compliant to the latest legislative requirements.

Q4, 2014

FET

3.4.2 Objective 2 – Improve Control & Management of Hazardous Waste Impact/Target Objective Action Due Date Responsibility

Hazardous Waste

Management

Reduce the volume of hazardous

waste generated on site by 5%

from 2010 baseline.

Complete the remaining bund repairs as

identified in the 2009 Bund Integrity report.

Divert small gas cyclinders and aerosol waste

from hazardous waste by installing equipment to

degass the gas and aerosol cyclinders.

Q2, 2011

Q3, 2011

EHS

FET

EHS = Environment, Health & Safety FET = Facilities Engineering Team LBP = Lean Business Process DES = Drug Eluting Stent


of 32

3.4.3 Objective 3 - Minimise the Environmental Impact of Aqueous Discharge and Contaminated Land/Groundwater Impact/Target Objective Action Due Date Responsibility

Minimise impact of

Aqueous Discharges &

Contaminated Land /

Groundwater

Implement recommendations of

2010 CC TV Pipeline Survey.

Continue with recommendations identified in the

2010 CC TV Pipeline survey and repair the

Grade Three observations.

Q4, 2011

FET

3.4.4 Objective 4 - Minimise the Environmental Impact of a Major Emergency Impact/Target Objective Action Due Date Responsibility

Management of a Major

Emergency

Expand of the onsite capability to

deal with chemical spills.

Update the definition of chemical spills and roll

out training to all site personnel.

Provide additional training for the dedicated spill

response team.

Q2, 2011

Q4, 2011

EHS

EHS

3.4.5 Objective 5 – Minimise the Environmental Impact of Non-Hazardous Waste Impact/Target Objective Action Due Date Responsibility

Non-hazardous Waste

Management

Divert 77% of non-hazardous

waste generated on site from

Landfill.

• Maximise diversion of canteen waste from

landfill to recycling.

Q4, 2011

EHS/Canteen

Staff

EHS = Environment, Health & Safety FET = Facilities Engineering Team LBP = Lean Business Process DES = Drug Eluting Stent


of 32

3.5 Solvent Management

3.5.1 Solvent Management Plan BSC Galway, as outlined in the Solvent and Fugitive Emission Plan (Attachment

1) complies with the requirements of S.I. No. 543 of 2002 (Emissions of Volatile

Organic Compounds from Organic Solvents) Regulations 2002 and S.I. No. 165

(Emissions of Volatile Organic Compounds from Organic Solvents (Amendment)

Regulations 2010.

BSC Galway meets the emission limit value (ELV) as defined in the Second

Schedule of the Regulations in Activity Number 8, “Other coating including

metal, plastic, textile” of 75mgC/Nm3 in waste gases and a fugitive ELV of less

that 20% of total solvent use. Additionally, BSC Galway meets the ELV’s for

solvents with the specified risk/hazard statements.

Table 2.16 Mass Balance of Solvent Usage and Emissions

Kg 2010 Kg 2009

Solvent Consumption 54,389 55,446

Solvent Air Emissions 3,446 2,977

Solvent Waste Disposal 63,429 67,880

Fugitive Emissions 6,799 6,239


of 32

4. RESIDUALS MANAGEMENT PLAN AND ENVIRONMENTAL LIABILITIES RISK ASSESSMENT

4.1 Residuals Management Plan (RMP)

In 2006, BSC Galway commissioned an external consultant to draw up a RMP

for the site to outline a plan, including costs, for the decommissioning of the

activity or part, thereof, to ensure minimum impact on the environment. This

plan was submitted to the Agency in 2006. The total potential cost identified for

the implementation of this plan for known liabilities was ca. Є1,449,000. This

plan is still valid although liability costs may now be somewhat less since the

introduction of the combined heat and power plant in August 2009.

4.2 Environmental Liabilities Risk Assessment (ELRA)

In 2007, BSC Galway commissioned an external consultant to draw up an ELRA

for the operation to identify and cost any liabilities that might be incurred as a

consequence of environmental pollution arising on the site, either directly or

indirectly, as a result of conducting the licensed activities. This assessment,

furthermore, indicated no additional potential costs from possible unknown

liabilities due to the low potential risk and mitigation measures in place. The

assessment was submitted to the Agency in 2007

4.3 Financial Provision for RMP & ELRA

Based on the RMP and the ELRA, the total required financial provision for the

site to meet known and unknown liabilities was estimated at €1,449,000. Boston

Scientific Corporation has put in place a Letter of Guarantee to cover the costs of

the known environmental liabilities. As the activities conducted on site have not

been materially altered the Letter of Guarantee as submitted to the Agency in

2007 still applies.


of 32

5. LICENCE SPECIFIC REPORTS The following reports are included as Attachments to this report:

Attachment 1 Solvent and Fugitive Emissions Plan for 2010

Attachment 2 Noise Monitoring Survey for 2010

Boston Scientific Corporation – Galway · Boston Scientific Corporation Galway (BSC Galway) is a...

Documents

Transcript of Boston Scientific Corporation – Galway · Boston Scientific Corporation Galway (BSC Galway) is a...